Moms@Home for Pregnancy-induced Hypertension

(Moms@Home Trial)

Overseen By Abigail Arthur, MBChB, MPH

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Massachusetts, Worcester

Disqualifiers: Severe hypertension, Preeclampsia, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This pilot study will examine the effects of a digital health approach, Moms@Home, on home blood pressure monitoring in a diverse population of pregnant women with hypertension.

Research Team

Lara Kovell, MD,MSc

Principal Investigator

University of Massachusetts Medical School, Worcester

Eligibility Criteria

This trial is for pregnant women aged 18-50 with gestational (20-26 weeks) or chronic hypertension (8-26 weeks), receiving care at UMass Memorial Health in Worcester, MA. Participants must be willing to share blood pressure data and comfortable using smartphones and mobile apps. Both English and Spanish speakers can join.

Inclusion Criteria

I am currently pregnant.

I am a patient at the UMass Memorial Health Obstetrics clinics in Worcester.

I am willing to share my blood pressure data from home.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Moms@Home app and digital BP monitor for home blood pressure monitoring and physical activity tracking

8 weeks

Baseline, 4 weeks, 8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Focus group interviews

Qualitative focus groups to assess ease of use, barriers, and facilitators related to the intervention and long-term maintenance

At least 3 months after randomization

Treatment Details

Interventions

• Moms@Home

Trial Overview The Moms@Home pilot study is testing a mobile health intervention designed to improve home blood pressure monitoring among diverse pregnant women with hypertension, comparing it against an enhanced standard of care.

Participant Groups

Group I: Moms@Home arm Experimental Treatment 1 Intervention

Participants randomized to Moms@Home will receive the Moms@Home app (± Samsung smartphone) to self-report data including home blood pressure monitoring values from a digital blood pressure monitor and physical activity data from a FitBit activity tracker.

Group II: Enhanced Standard Care arm Active Control 1 Intervention

Participants randomized to Enhanced Standard Care (ESC) will receive a paper diary to self-report data including measurements from a digital blood pressure monitor.

Who Is Running the Clinical Trial?

University of Massachusetts, Worcester

Lead Sponsor

Trials

372

Recruited

998,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+